BioCentury
ARTICLE | Clinical News

Ocriplasmin regulatory update

July 9, 2012 7:00 AM UTC

FDA accepted and granted Priority Review to a BLA from ThromboGenics for ocriplasmin to treat symptomatic vitreomacular adhesion. The PDUFA date is Oct. 17. The agency's Dermatologic and Ophthalmic Drugs Advisory Committee will meet on July 26 to discuss the application. ThromboGenics resubmitted the BLA in April. The company withdrew the application in February after receiving notice that FDA intended to grant the application a 6-month Priority Review. The company said the resubmission would allow the company to meet the pre-approval inspection timelines for Priority Review (see BioCentury, April 23). ...